Agency classClass IIOur severity:High FDA (Devices)·Z-2116-2025·Announced 2025-07-23

SwabCap disinfecting caps may have an incomplete seal allowing alcohol evaporation

SwabCap Disinfecting Caps for needlefree connectors are being recalled because an incomplete seal may let isopropyl alcohol evaporate, which may result in inadequate disinfection. 1,445,600 units affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Risk-of-harm product: a disinfecting cap that may not disinfect the connector it is applied to, with no infection reported in the source.

Plain-English summary

SwabCap Disinfecting Cap for Needlefree Connectors, supplied as SwabSleeve (REF SCXT3-5-2000) and SwabCap in 200-count boxes (REF SCXT3-2000), is being recalled. The action covers 1,445,600 units.

According to the manufacturer, due to a manufacturing issue the disinfecting cap may have an incomplete seal between the foil lid and the plastic container, which may result in isopropyl alcohol evaporating from the sponge and in turn may result in inadequate disinfection. The FDA classified the action as Class II. The source does not report any infection having occurred.

Distribution was worldwide, including nationwide in the United States. The caps are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REF numbers, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product: SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Disinfecting cap
Hazard: incomplete-seal
alcohol-evaporation
inadequate-disinfection
class-ii
Affected units: 1,445,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

REF/UDI-DI/Lot(Expiration): SCXT3-5-2000/10887709097107/14258739(1-Dec-26)
14258743(1-Feb-26)
14258744(1-Dec-26)
14264200(1-Dec-26)
14272241(1-Dec-26)
14272248(1-Dec-26)
14287456(1-Dec-26)
14287459(1-Dec-26)
14287480(1-Dec-26)
14287482(1-Dec-26)
14287485(1-Dec-26)
14294832(1-Dec-26)
14272254(1-Dec-26)
14310313(1-Dec-26)
14310425(1-Dec-26)
14323354(1-Dec-26)
14287475(1-Dec-26)
14294840(1-Dec-26)
14321645(1-Jan-27)
14321652(1-Jan-27)

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Same manufacturer · ICU Medical, Inc.

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Same hazard · incomplete seal